Dr. Daria Kim

Herausgeberschaften

Rebuilding Ukraine - The Case of the Health Sector (Max Planck Institute for Innovation and Competition Research Paper, No. 24-02), Max Planck Institute for Innovation and Competition, Munich 2024, 59 S.

• This collection is based on the presentations given at the roundtable "Rebuilding Ukraine: The Case of the Health Sector" held on 21 March 2023 at the Max Planck Institute for Innovation and Competition in Munich. The reasons for organising this exchange are apparent. Even during times of peace, access to healthcare, as a basic necessity, is vulnerable in many nations. In wartime, it becomes a matter of survival on a national scale. Overcoming multiple challenges requires a concerted effort and a comprehensive approach to the regulatory framework in the health sector. The compilation features contributions by experts from specialised domains, including intellectual property law, regulation of drug research and development, safety regulation, and the regulation of pharmacy activity. While not meant as an all-encompassing policy proposal, this collection contains valuable insights and suggestions that, cumulatively, can show a way forward in addressing the imminent and long-term consequences of war.
  This collection is a tribute to Ukrainian scholars, their dedication and resilience. Despite the challenging conditions, they carry on their work uncovering the imperfections of governance structures and seeking pathways to their improvement. As any publication takes time, the factual information inevitably becomes outdated. Whenever feasible, sources with relevant dates are provided for checking more up-to-date statistics. However, the primary intent was not to provide a list of facts but rather to explore the economic, institutional, and legal factors that are foundational for a sustained and sustainable health sector.
• Rebuilding_Ukraine_Healthcare_2024.pdf
• Available at SSRN

Contemporary Issues in Pharmaceutical Law: Setting the Framework and Exploring Potential Policy Options (Routledge research in intellectual property), Routledge, New York 2017, viii + 249 S. (gemeinsam mit Brian Mercurio).

Monographien und andere selbständige Publikationen

Access to Non-Summary Clinical Trial Data for Research Purposes Under EU Law (Munich Studies on Innovation and Competition, Volume 16), Springer, Berlin 2021, XVIII + 300 S.

• This book draws a unique perspective on the regulation of access to clinical trial data as a case on research and knowledge externalities. Notwithstanding numerous potential benefits for medical research and public health, many jurisdictions have struggled to ensure access to clinical trial data, even at the level of the trial results. Pro-access policy initiatives have been strongly opposed by research-based drug companies arguing that mandatory data disclosure impedes their innovation incentives. Conventionally, access to test data has been approached from the perspective of transparency and research ethics. The book offers a complementary view and considers access to individual patient-level trial data for exploratory analysis as a matter of research and innovation policy. Such approach appears to be especially relevant in the data-driven economy where digital data constitutes a valuable economic resource. The study seeks to define how the rules of access to clinical trial data should be designed to reconcile the policy objectives of leveraging the research potential of data through secondary analysis, on the one hand, and protecting economic incentives of research-based drug companies, on the other hand. Overall, it is argued that the mainstream innovation-based justification for exclusive control over the outcomes of research and development can hardly rationalise trial sponsors’ control over primary data from trials. Instead, access to such data and its robust analysis should be prioritised.
• https://doi.org/10.1007/978-3-030-86778-2

Beiträge in Sammelwerken, Kommentierungen, Handbüchern und Lexika

Patents for Enabling Technologies: The Puzzle of the Normative Delineation of Protection, in: Kreation Innovation Märkte - Creation Innovation Markets - Festschrift Reto M. Hilty, Springer, Berlin; Heidelberg 2024, 551 - 562. DOI

• This contribution reflects on two technologies enabling cumulative innovation – new genomic techniques (NGTs) and machine learning (ML). These broadly applicable enabling technologies illustrate a persistent dilemma in patent policy and the economics of knowledge: How to reconcile the expected incentive effect of patents on knowledge creation with their apparent restrictive effect on knowledge dissemination? After reviewing the theoretical premises and insights from empirical literature, the paper offers preliminary observations on why NGTs and ML, while sharing many similarities, markedly differ in terms of diffusion through their downstream applications. In conclusion, it suggests that compulsory licensing of patents for enabling technologies, such as research tools, should be considered as an instrument for promoting cumulative research and innovation.

A Context-Based Definition of a Copyrightable Work – In Search of the Justification, in: Phillip Hellwege, Marta Soniewicka (Hg.), Interdisciplinary Approaches to Law. A Polish-German Perspective, Mohr Siebeck 2024, forthcoming.

Test Data Protection, in: Paul Torremans et al. (Hg.), Encyclopedia of Intellectual Property Law, Edward Elgar Publishing, Cheltenham, UK; Northampton, MA, USA 2024, forthcoming.

Тowards a Greater Role of Technology Transfer in Rebuilding Ukraine: General overview, in: В.В. Поєдинок (Hg.), Другі наукові читання пам’яті професора Пронської Граціелли Василівни. Економіка війни та повоєнний економічний розвиток України: проблеми, пріоритети, завдання правового регулювання, Видавництво Ліра-К, Київ 2023, 17 - 20 (gemeinsam mit Anastasiia Lutsenko).

Test Data Exclusivity: An Elusive Pursuit to Strike a Balance Between Affordable Drugs and Investment Incentives, in: Enrico Bonadio, Patrick R. Goold (Hg.), The Cambridge Handbook of Non-Creative Intellectual Property, Cambridge University Press, Cambridge 2023, 54 - 72. DOI

• Test data exclusivity (TDE) is a regulatory mechanism of suspending price competition in the drug market rationalised on the grounds of protecting innovation incentives of originator companies. Under international trade law, it is considered a subset of intellectual property (IP). While its impact on innovation remains ambiguous, TDE has been criticised at length as an impediment to affordable medicine and the right to health, an obstacle to transparency in medical research, a case of ‘ratcheting up’ of international IP standards, and a threat to TRIPS flexibilities.

Incentives for Data Sharing as a Case on (Regulating) Knowledge Externalities, in: A Critical Mind. Hanns Ullrich’s Footprint in Internal Market Law, Antitrust and Intellectual Property (MPI Studies on Intellectual Property and Competition Law, 30), Springer, Berlin 2023, 407 - 439. DOI

• This contribution reflects on the question posed by Professor Hanns Ullrich: Which concepts and principles of intellectual property law inform the design of a regulatory framework for the data economy? Even though data and knowledge do not lend themselves to form a perfect analogy, their governance underlies the same dilemma of whether, and to what extent, resources that are non-rivalrous in use should be treated as excludable or a non-excludable economic goods. The analysis focuses on the ‘access-incentives stalemate’ over device-generated data and takes recourse to literature on economics of knowledge and innovation in search of guidance as to how the trade-off between the broad accessibility of data and the protection of innovation incentives should be resolved.

Rational Decision-making in Drug Approval Regulation and Innovation: Policy Analysis Perspective, in: Bryan Mercurio, Daria Kim (Hg.), Contemporary Issues in Pharmaceutical Patent Law - Setting the Framework and Exploring Policy Options (Routledge research in intellectual property), Routledge, London; New York 2017, 203 - 224.

Aufsätze

What Is Emerging in Artificial Intelligence Systems?, Max Planck Law Perspectives 2024, 17.07.2024. DOI

• This note examines in what sense qualities often attributed to AI can be considered ’emergent’ by drawing on perspectives on complexity. It goes on to identify the predictive capacity of neural networks as weakly emergent, aligning with explanatory reductionism, and highlights the need to appreciate human causality in normative assessment.

Why AI Cannot and Should Not Become a ‘Black Hole’ for Causation in Tort Law, Tort Law 2024, forthcoming.

Data Usability as a Parameter of Rights and Obligations under the EU Data Act, Journal of Intellectual Property, Information Technology and Electronic Commerce Law 15, 2 (2024), 139 - 155 (gemeinsam mit Man Wai Kwok).

• As an instrument for advancing the data economy, the EU Data Act aspires to enhance the accessibility of data generated through the use of connected products and related services, thereby unlocking the potential of data for the benefit of society. This article focuses on data usability as an equally crucial factor in harnessing value from data, an aspect that gained recognition only in the later stages of the legislative process. In particular, we examine the technical state of data, which is both a technical factor for realising the value of data and a legal parameter delineating the scope of data access and usage rights, along with the respective obligations introduced by the Data Act.
  
  Our analysis finds that data usability is not thoroughly considered in the Data Act and is only minimally addressed within the framework of its data-sharing regime. We identify several concepts bearing on the technical state of data – including the notions of ‘pre-processed data’, ‘readily available data’, ‘simple operation’, ‘insignificant investment’, and ‘disproportionate effort’ – that remain unclear, leading to uncertainties regarding the scope of data-sharing obligations. The attainment of the policy goals will, to an impactful extent, hinge on the interpretation and application of these criteria. While acknowledging that the final version of the Data Act represents an improvement over the initial proposal in terms of addressing data usability, we contend that the imposition of restrictive criteria on the scope of ‘readily available data’ and ‘pre-processed’ data is not justified, whether viewed from the perspective of technical necessity, legal certainty, or a balance of interests.
• https://www.jipitec.eu/jipitec/article/view/405/398
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 24-04

Der Datenbankschutz sui generis nach dem Data Act - Having the Cake and Eating It Too?, MMR - Beilage 2024, 87 - 91.

New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector - Position Statement of the Max Planck Institute for Innovation and Competition: Munich, 8 January 2024, GRUR Int 73, 4 (2024), 323 - 339 (gemeinsam mit Michael Kock et al.). DOI

• On 5 July 2023, the European Commission proposed a regulation aiming to ease the requirements for the marketing authorisation of plants obtained through certain new genomic techniques (NGTs) within the European Union (EU). While NGTs are expected to become more attractive to breeders and farmers, the complexity of the intellectual property (IP) landscape surrounding these techniques and resulting products may negatively impact technology diffusion and innovation. Given numerous concerns related to IP protection for NGTs and NGT-derived plants, this Position Statement from the Max Planck Institute for Innovation and Competition presents a set of policy recommendations for facilitating access to and utilisation of IP-protected NGTs and NGT-derived products in the breeding sector.

Artificial Intelligence Should Not Become a “Black Hole” for Human Agency in Tort Law, The Tort Law Review 29, 2 (2023), 52 - 168.

• This article analyses the implications of the tendency to anthropomorphise artificial intelligence (AI) systems for tort law. It shows that the view of AI technology as “autonomous”, “unexplainable” and “unpredictable” can misguide the “fit-for-purpose” assessment of the existing liability regimes. The analysis points out that risks and harm associated with AI technology are not inflicted by AI systems as such but are mediated through AI applications, while the main challenge for the allocation of tortious liability lies in the highly distributed causation between human conduct and harm. Overall, it is argued that humans can and should retain agency over mitigating technological risks and internalising harmful effects, even when the sources of those risks and harms are highly distributed.
• TLR_DK_AI_v2.pdf

Revisiting the Framework for Compulsory Licensing of Patents in the European Union – Reflections on the European Commission’s Initiative, GRUR Int 72, 5 (2023), 471 - 482 (gemeinsam mit Matthias Lamping et al.). DOI

• Within the scope of its initiative on ‘Compulsory Licensing in the EU’,8 the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more ‘adequately prepared and coordinated to tackle future crises’.9 The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject.
  
  Depending on the issue to be addressed and the extent of the Commission’s willingness to reform, different regulatory approaches are conceivable. Subject to compatibility with the principles of subsidiarity and proportionality, these include:
  
  Rather than making concrete recommendations on the regulatory approach, this paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence.
  
  – soft law measures, such as guidelines and recommendations;
  
  – harmonisation of national laws (substantive and/or procedural);10
  
  – judicial cooperation (i.e. mutual recognition of judgments and of decisions in extrajudicial cases);11
  
  – centralisation of granting and/or judicial review competences;
  
  – creation of a supranational compulsory licence;
  
  – or any combination thereof.

On Words That Come Easy, GRUR Int 72, 5 (2023), 433 - 434. DOI

The Paradox of the DABUS Judgment of the German Federal Patent Court, GRUR Int 71, 12 (2022), 1162 - 1166. DOI

• The judgment of the German Federal Patent Court (Bundespatentgericht) in the Food container case1 holds a unique place in the worldwide series of DABUS2 cases. On the one hand, it confirmed that an artificial intelligence (AI) system cannot be regarded as an inventor under patent law, which has so far been a dominant trend in other jurisdictions concerned with the matter.3 On the other hand, it allowed the applicant Stephen Thaler, who insisted on not having invented the food container, to be designated as the inventor in the patent application, thus, opening up an opportunity for him to become the patent owner. While the case outcome may appear as a constructive compromise, one may question the internal consistency of the court’s reasoning. This analysis shows that the judgment is paradoxical in that, by allowing Thaler to be deemed the inventor of the food container, it contradicts the very principle of human creativity underlying the inventor’s (moral) right to be named – the principle that was relied upon by the adjudicating Board when denying the designation of DABUS as the inventor.

Clarifying Assumptions About Artificial Intelligence Before Revolutionising Patent Law, GRUR Int 71, 4 (2022), 295 - 321 (gemeinsam mit Maximilian Alber et al.). DOI

• This paper examines several widespread assumptions about artificial intelligence, particularly machine learning, that are often taken as factual premises in discussions on the future of patent law in the wake of ‘artificial ingenuity’. The objective is to draw a more realistic and nuanced picture of the human-computer interaction in solving technical problems than where ‘intelligent’ systems autonomously yield inventions. A detailed technical perspective is presented for each assumption, followed by a discussion of pertinent uncertainties for patent law. Overall, it is argued that implications of machine learning for the patent system in its core tenets appear far less revolutionary than is often posited.

Redundant Trials Can Be Prevented, if the EU Clinical Trial Regulation is Applied Duly, BMC Medical Ethics 21 (2020) (gemeinsam mit Joerg Hasford). DOI

• The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials – studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

'AI-Generated Inventions': Time to Get the Record Straight?, GRUR Int 69, 5 (2020), 443 - 456. DOI

• This article attempts to clarify the notion of an ‘AI-generated’ invention, an issue which has triggered an intense debate on the future of patent law and policy. While there is a general consensus that such inventions are incompatible with the concept of human inventorship, it remains largely unclear to what extent concerns regarding ‘non-human’ ingenuity can be justified. Most uncertain is how AI ‘autonomously generates’ inventions, and in what way 'AI-generated' inventions differ from inventions developed with the aid of AI.
  Drawing on the extensive literature review, this article depicts AI techniques as methods of computational problem solving. It emphasises that such methods should not be equated with a computer’s ‘cognitive autonomy’. Further, it clarifies that the types of AI that have been most debated in the patent law literature ‒ artificial neural networks and evolutionary algorithms ‒ essentially require detailed instructions that determine how the relation between inputs and outputs is derived through computation. Accordingly, it is argued that, as long as computers rely on instructions defined by a human as to how solve a problem, the separation between human and non-human (algorithmic) ingenuity is, in itself, artificial. Ultimately, the article calls for a broader technical inquiry that would elucidate the relevance of the currently debated normative concerns over ‘non-human inventorship’ against the background of the technological state of the art.

Transparency Policies of the European Medicines Agency: Has the Paradigm Shifted?, Oxford Medical Law Review 25, 3 (2017), 456 - 483. DOI

• This article reflects on the state of play as regards access to non-summary clinical trial data in the European Union (EU). In particular, it examines the scope of access under the recent transparency policies of the European Medicines Agency (EMA) that attempt to break away from the presumptively confidential treatment of clinical trial data. In light of the emerging case law of the Court of Justice of the European Union on clinical trial data disclosure, it remains highly uncertain what data, and under what conditions, can be lawfully released by the EMA. Under the applicable regulations, the scope of the accessible data depends on the interpretation of commercially confidential information—the notion derived from the exception to the fundamental right of access to documents. Accordingly, the analysis focuses on the application of this exception, taking into account the specifics of clinical data, the context in which disclosure occurs, and the interests that are at stake. The main complexity is found in defining the scope of the relevant and legitimate interests to be balanced when applying the exception. Overall, it is argued that the current regulatory framework does not provide a sufficient legal basis to support the objectives pursued by the EMA’s policies.

No One's Ownership as the Status Quo and a Possible Way Forward: A Note on the Public Consultation on Building a European Data Economy, GRUR Int 66, 8/9 (2017), 697 - 705.

• From 10 January to 26 April 2017 the European Commission carried out a public consultation on Building a European Data Economy. The key legal question of the initiative is how access and use rights in industrial data, as a digital resource, should be defined and allocated in order to achieve the objectives of the EU data-driven economy. The present analysis focuses on the proposals for new rights in industrial data, and takes a methodological perspective of designing a regulatory intervention. The overall argument is that the ‘intervention logic’ behind the proposals for a data producer’s right does not appear straightforward, and that keeping the scenario of non-intervention by such rights might not be the least optimal option among the possible ‘ways forward’.
• Also published in Journal of Intellectual Property Law & Practice 13,2 (2018), 154 - 165

Protecting Trade Secrets under International Investment Law: What Secrets Investors Should Not Tell States, John Marshall Review of Intellectual Property Law 15, 2 (2016), 999 - 1027.

• The article addresses specifics of trade secret protection under international investment law. As a particular example, it analyzes protection of pharmaceutical regulatory data against the background of the growing public policy campaign for broader access to clinical trial data and the recent unprecedented practice of the European Medicines Agency of disclosing clinical dossiers submitted for drug marketing approval. Given the significant role of foreign direct investment in the global pharmaceutical industry and substantial, exponentially increasing costs incurred by drug originator companies in conducting clinical trials, the prospect of investor-state dispute over data disclosure does not appear purely hypothetical. The question is whether investor-state arbitration is an apt instrument to protect originators' data against disclosure by drug regulatory authorities. The analysis suggests that the application of standards of international investment protection depends on the specifics of information at issue, its value, and functions in investors' commercial operations. With regard to pharmaceutical test data, it is argued that the prospects of investor-state arbitration are rather unfavorable for the investor, when data is disclosed to support policy objectives in public healthcare and medical innovation.

Knowledge Sharing as a Social Dilemma in Pharmaceutical Innovation, Food and Drug Law Journal 71, 4 (2016), 673 - 709.

• This article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyzes the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes drug sponsors' innovation incentives and that access facilitates new drug development. These claims are characterized in terms of public-good and common-resource dilemmas. The analysis finds confidentiality protection ofprimary research data plays an ambiguous role. While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common- resource problem, in view ofdata as a source ofscientific knowledge. It is argued that the claim by the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against pro-access policies. While much attention has been paid to the problem ofappropriability ofdrug R&D investment, this analysis highlights another consequence resulting from the private provision of clinical trials, i.e., factual confidentiality and possession of data by drug sponsors. The associated social costs are qualified in terms of internalized knowledge externalities. Since, in a competitive environment, companies are unlikely to change the strategy of non-sharing of primary data, the resulting economic inefficiencies at the sector level call for regulatory intervention. To reconcile the competing policy objectives, it is proposed that the rules ofaccess should be designed in such a way that third-party use of primary data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximized when the "cooperative choice" (i.e., when everyone shares data) becomes the "dominant strategy." This can be achieved only when access is not subject to the authorization of the initial trial sponsors, and when primary data is aggregated, refined, and managed on the collective basis.

Foreign Direct Investment in the Pharmaceutical Industry: Why Singapore and not Hong Kong, Asian Journal of Comparative Law 10, 2 (2015), 235 - 257 (gemeinsam mit Bryan C. Mercurio). DOI

• This article began as mere curiosity over what appeared to be a paradox – Singapore and Hong Kong share countless economic and geopolitical similarities and compete vigorously for foreign direct investment (FDI), yet only the former has become a pharmaceutical hub while the latter struggles to attract any FDI in the sector. To find the reason for the “drastic” difference in pharmaceutical FDI, we compare the economic, legal, policy, and regulatory frameworks of the two jurisdictions focusing on the factors that have been identified in the economic literature as having the most relevance for FDI decision-making. The analysis discounts economic and legal factors before finding variances in policy and regulatory frameworks as the critical difference accounting for the disparity in the pharmaceutical FDI. Given that Hong Kong occasionally considers transforming itself into the “pharmaceutical centre for the Asia-Pacific”, this article calls for a change in policy approach and strategy before this aspiration is considered more realistically.

Enabling Access to Clinical Trial Data: When is Unfair Use Fair?, Chicago-Kent Journal of Intellectual Property Law 14, 2 (2015), 521 - 552.

• This inquiry is prompted by the unprecedented policy of the European Medicines Agency that enables the disclosure of clinical trial reports submitted for drug marketing authorization, effective as of January 1, 2015. It addresses the question whether such practice is in compliance with the international standard of clinical data protection under Article 39.3 of the TRIPS Agreement. Most scholarly and policy debate regarding this provision analyzes whether it precludes the referential use of data to facilitate the approval of a generic drug. Rather than focusing on a particular use, this Article seeks to identify the principle underlying the protection obligation by which the legitimacy of "use X" can be evaluated. In doing so, it interprets the provision from literal, historical and teleological perspectives, and it analyzes a peculiar overlap between three legal regimes: unfair competition, trade secret, and suigeneris data protection. The proposed principle allows avoidance of situations where, due to the ambiguous notion of unfair commercial use, the protection of data under the TRIPS Agreement can be stretched indefinitely. With regard to data disclosure for experimental use, it is argued that the protection obligation under 39.3 TRIPS does not justify monopoly type protection of clinical trial data, neither does it require the reservation of experimental use exclusively for the data originator, even if such use can have commercial benefits for competitors.

Patently Lacking: A Call for Systemic Review of Pharmaceutical Law and Policy - A Case Study of Hong Kong, Asian Journal of WTO & International Health Law and Policy 9, 1 (2014), 63 - 122 (gemeinsam mit Bryan C. Mercurio).

• This article offers preliminary findings into the pharmaceutical laws and policy of Hong Kong. Applying a framework approach to
  identifying the linkages between pharmaceutical patents and policy
  objectives in the areas of public health, medical innovation and pharmaceutical industry development, the article examines the pharmaceutical patent regime as an integrated system of patent and
  regulatory laws which govern pharmaceutical patents and products
  and explores the way such provisions operate at a complex intersection of
  policy objectives, priorities and mandates. The study reveals contradictions in the way in which the provisions are implemented within Hong Kong's pharmaceutical
  patent system as well as certain discrepancies between the system and broader governmental agendas. In so doing, the article demonstrates the importance of clear policy objectives in intellectual property, innovation and pharmaceutical industry as well as the need for
  sector specific empirical studies and an integrated approach for establishinga better
  functioning pharmaceutical patent regime. The perspectives and considerations revealed in the analysis are of
  interest and applicable to other
  jurisdictions in that they provide a
  framework for policy and law makers to implement pharmaceutical
  legal and regulatory provisions in a more coherent and systematic manner conducive to national priorities and balancing interests and needs of the stakeholders and the populace.

Forschungspapiere

Regulating Genome-Edited Products – an International Trade Law Perspective (Max Planck Institute for Innovation & Competition Research Paper, No. 24-13), 2024, 51 S. (gemeinsam mit Tolulope Anthony Adekola et al.).

• This paper provides a preliminary assessment of the compliance of national marketing regulation concerning genome-edited food products with international trade law. It presents an overview of global regulatory trends in this area and focuses on the compatibility of the diverging regulatory approaches with World Trade Organization (WTO) law, particularly the Agreement on Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT). Overall, the analysis finds significant potential for trade concerns under WTO law. As consumer choice is becoming the primary justification for labelling requirements, the focus of the assessment of NGT related measures will likely shift towards the TBT Agreement.
• Available at SSRN

Fostering Contractual Pathways for Responsible AI Data and Model Sharing for Generative AI and Other AI Applications. GPAI I&C WG: Protection Innovation, Intellectual Property (IP) Project. Report, 2023, 44 S. (gemeinsam mit GPAI, The Global Partnership on Artificial Intelligence et al.).

• https://gpai.ai/projects/responsible-ai/IC_Intellectual%20Property%20project.pdf

GPAI IP Expert - Preliminary Report on Data and AI Model Licensing, 2022, 36 S. (gemeinsam mit Lee Tiedrich et al.).

• https://gpai.ai/projects/innovation-and-commercialization/intellectual-property-expert-preliminary-report-on-data-and-AI-model-licensing.pdf

Artificial Intelligence Systems as Inventors? A Position Statement of 7 September 2021 in View of the Evolving Case-Law Worldwide (Max Planck Institute for Innovation & Competition Research Paper, No. 21-20), 2021, 11 S. (gemeinsam mit Josef Drexl et al.). DOI

• On 30 July 2021 the Federal Court of Australia handed down a decision in which it accepted that an artificial intelligence (AI) system called DABUS can be deemed the inventor under Australian patent law. While the decision appears ground-breaking at first sight, it was mostly based on unverified assumptions regarding the technical capabilities of AI systems in general and DABUS in particular. Furthermore, the decision omits important questions regarding the consequences that may follow from attributing inventorship to an entity that lacks legal capacity without undertaking a comprehensive analysis that would justify such attribution. This Position Statement highlights the shortcomings of the decision and points to those factual and legal questions that need to be answered first before recognising AI systems as inventors. While it responds primarily to the decision of the Australian Federal Court, the presented arguments can be of relevance for any jurisdiction dealing with the question of whether an AI system can be deemed an inventor under patent law.

Ten Assumptions About Artificial Intelligence That Can Mislead Patent Law Analysis (Max Planck Institute for Innovation & Competition Research Paper, No. 21-18), 2021, 77 S. (gemeinsam mit Maximilian Alber et al.). DOI

• The paper examines a set of assumptions about artificial intelligence, particularly machine learning, often taken as factual premises in discussions on the future of patent law in the wake of ‘artificial ingenuity’. The objective is to draw a more realistic and nuanced picture of the human-computer interaction in solving technical problems than where AI systems autonomously generate inventions. A detailed technical perspective is presented for each assumption, followed by a discussion of specific uncertainties under patent law. Overall, it is argued that none of the posited assumptions on closer examination appears to raise fundamental uncertainty about the appropriateness of the patent system.

Technical Aspects of Artificial Intelligence: An Understanding from an Intellectual Property Law Perspective (Max Planck Institute for Innovation & Competition Research Paper, No. 19-13), 2019, 15 S. (gemeinsam mit Josef Drexl et al.).

• The present Q&A paper aims at providing an overview of artificial intelligence with a special focus on machine learning as a currently predominant subfield thereof. Machine learning-based applications have been discussed intensely in legal scholarship, including in the field of intellectual property law, while many technical aspects remain ambiguous and often cause confusion.
  This text was drafted by the Research Group on the Regulation of the Digital Economy of the Max Planck Institute for Innovation and Competition in the pursuit of understanding the fundamental characteristics of artificial intelligence, and machine learning in particular, that could potentially have an impact on intellectual property law. As a background paper, it provides the technological basis for the Group’s ongoing research relating thereto. The current version summarises insights gained from background literature research, interviews with practitioners and a workshop conducted in June 2019 in which experts in the field of artificial intelligence participated.
• Available at SSRN

Stellungnahmen

Revisiting the Framework for Compulsory Licensing of Patents in the European Union, 2023, 27 S. (gemeinsam mit Matthias Lamping et al.).

• Within the scope of its initiative on “Compulsory Licensing in the EU”, the European Commission launched a call for evidence on 1 April 2022 and a public consultation on 7 July 2022 with the aim of gathering views from stakeholders. The objective of this initiative is to explore the possibility of revising the framework for compulsory licensing in the EU to make it more “adequately prepared and coordinated to tackle future crises”. The authors of this position paper welcome the Commission’s attempt to reinvigorate the public discourse on this important subject. This paper addresses selected aspects by way of a preliminary, non-exhaustive note on: the proposed reform’s scope and the grounds for a compulsory licence; the requirements of prior negotiation and licensing failure; government use; procedural matters; compulsory licences for patent applications and products; the relation with other regulations and sui generis regimes (i.e. trade secret protection, regulatory data protection, and supplementary protection certificates); the concept of adequate remuneration; compulsory licences for European patents with unitary effect; and the exhaustion of products placed on the market under a compulsory licence.
• Opinion published as Max Planck Institute for Innovation & Competition Research Paper No. 23-07

Position Statement of 5 July 2022 on the Decision of the WTO Ministerial Conference on the TRIPS Agreement adopted on 17 June 2022, 2022, 8 S. (gemeinsam mit Reto M. Hilty et al.).

• On 17 June 2022, after nearly one and a half years of intense debate concerning the proposal to waive IP protection in view of the COVID-19 pandemic, the Ministerial Conference of the World Trade Organization adopted a decision on the TRIPS Agreement. It has not waived any intellectual property rights as such but instead mainly clarified the application of the existing TRIPS flexibilities, in particular, regarding compulsory licensing of patents. The Position Statement shows that the Ministerial Decision makes no substantive difference in the existing international legal framework, except for lifting the limitation on the exportation of vaccines manufactured in accordance with the Decision. To the extent that the Decision can make the application of TRIPS flexibilities more expedient, it is to be welcomed. At the same time, it is argued that such facilitating effect should not be limited to, or justified by, the exceptional circumstances of the COVID-19 pandemic. More critically, it should not be restricted to COVID-19 vaccines, of which there is currently no shortage – rather, the same level of TRIPS flexibilities should apply to all medicinal products needed to overcome the COVID-19 pandemic.
• 2022-07-05__2._Position_Statement_Covid_IP_Waiver.pdf
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 22-14

Position Statement of the Max Planck Institute for Innovation and Competition of 25 May 2022 on the Commission's Proposal of 23 February 2022 for a Regulation on Harmonised Rules on Fair Access to and Use of Data (Data Act), 2022, 124 S. (gemeinsam mit Josef Drexl et al.).

• On 23 February 2022, the European Commission issued a Proposal for a Regulation on harmonised rules on fair access to and use of data (Data Act). The overarching objective of the Proposal is to ‘ensure fairness in the digital environment, stimulate a competitive data market, open opportunities for data-driven innovation and make data available for all’. The Institute hereby presents its Position Statement that features a comprehensive analysis of whether and to what extent the proposed rules might reach the envisaged objectives. It comments on all parts of the Proposal, including the new IoT data access and use right. Finally, the Institute offers a set of recommendations as to how the proposed provisions should be amended in the legislative process to align them better with the objectives of the Data Act.
• Position_Statement_MPI_Data_Act_Formal__13.06.2022.pdf
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 22-05

Artificial Intelligence Systems as Inventors? A Position Statement of 7 September 2021 in View of the Evolving Case-Law Worldwide, 2021, 11 S. (gemeinsam mit Josef Drexl et al.).

• MPI_Position_statement_AI_Inventor_2021-08-09.pdf

Covid-19 and the Role of Intellectual Property - Position Statement of the Max Planck Institute for Innovation and Competition of 7 May 2021, 2021, 11 S. (gemeinsam mit Reto M. Hilty et al.).

• In this Statement, the authors take a position on the waiver of intellectual property (IP) protection currently being considered by the members of the World Trade Organisation. The waiver was initiated by India and South Africa as a measure to enable rapid access to affordable medical products that are necessary to combat Covid-19. The initiative gained momentum after the US decided to support it. The authors do not consider this path to be expedient. The Statement presents factual and legal arguments why a comprehensive waiver of IP protection is unlikely to be a necessary and suitable measure towards the pursued objective. Overall, it argues that IP rights may so far have played an enabling and facilitating rather than hindering role in overcoming Covid-19. The global community might not be better off if IP rights are waived, neither during nor after the pandemic. There are more efficient and direct ways to supply developing countries with vaccines quickly – if the industrialised countries are willing to do their share.
• 2021_05_25_Position_statement_Covid_IP_waiver.pdf
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 21-13

Artificial Intelligence and Intellectual Property Law - Position Statement of the Max Planck Institute for Innovation and Competition of 9 April 2021 on the Current Debate, 2021, 26 S. (gemeinsam mit Josef Drexl et al.).

• This Position Statement presents a broad overview of issues arising at the intersection of AI and IP law based on the work of the Max Planck Institute for Innovation and Competition research group on Regulation of the Digital Economy. While the analysis is approached mainly from a perspective de lege lata, it also identifies questions which require further reflection de lege ferenda supported by in-depth interdisciplinary research. The scope is confined to substantive European IP law, in particular, as regards copyright, patents, designs, databases and trade secrets. Specific AI-related issues are mapped out around the core questions of IP law, namely, the eligibility for protection under the respective IP regimes, allocation of rights and the scope of protection. The structure of the analysis reflects three key components of AI: inputs required for the development of AI systems, AI as a process and the output of AI applications. Overall, it is emphasised that, while recent legal and policy discussions have mostly focused on AI-aided and AI-generated output, a more holistic view that accounts for the role of IP law across the AI innovation cycle is indispensable.
• MPI_PositionPaper__SSRN_21-10.pdf
• Also published as Max Planck Institute for Innovation & Competition Research Paper No. 21-10

Stellungnahme zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts, 2020, 16 S. (gemeinsam mit Luc Desaunettes-Barbero et al.).

• Das Max-Planck-Institut für Innovation und Wettbewerb nimmt hiermit zum Diskussionsentwurf eines Zweiten Gesetzes zur Vereinfachung und Modernisierung des Patentrechts Stellung, der vom Bundesministerium der Justiz und für Verbraucherschutz im Januar 2020 vorgelegt wurde. Das Institut begrüßt die Initiative des Ministeriums, empfiehlt im Hinblick auf die Beschränkung des patentrechtlichen Unterlassungsanspruchs und die Stärkung des Schutzes von Geschäftsgeheimnissen in Patentstreitsachen jedoch gewisse Präzisierungen.
  Mit Blick auf die Beschränkung des Unterlassungsanspruchs nach Maßgabe des Grundsatzes der Verhältnismäßigkeit wird vorgeschlagen, die Verhältnismäßigkeitsprüfung nicht auf einen Anwendungsfall der Gebote von Treu und Glauben zu reduzieren, sondern im Sinne der ratio legis des Patentrechts zu verstehen; insoweit als Maßnahme zur Verhinderung dysfunktionaler Effekte des Ausschließlichkeitsrecht bzw. des damit verbundenen Unterlassungsanspruchs. Zur Veranschaulichung des Ansatzes wird auf die Fallgruppen der komplexen Produkte, der Patentverwerter und der standardessenziellen Patente Bezug genommen, ohne sie jedoch im Detail durchzuprüfen. Mit Blick auf die im Rahmen der Verhältnismäßigkeitsprüfung vorzunehmende Interessenabwägung wird darauf hingewiesen, dass die Interessen des Patentinhabers gegenüber jenen des Verletzers keinen grundsätzlichen Vorrang genießen. Darüber hinaus sind bei der Abwägung nicht nur die Interessen der Streitparteien, sondern auch jene Dritter, insbesondere das öffentliche Interesse, zu berücksichtigen.
  Mit Blick auf den Schutz von Geschäftsgeheimnissen in Patentstreitsachen verweist die Stellungnahme auf Unzulänglichkeiten des Verfahrens in Geschäftsgeheimnisstreitsachen, die durch die angedachte Anwendung der entsprechenden Vorschriften auf das Patentstreitverfahren übertragen werden. Hingewiesen wird auch auf eine mögliche Regelungslücke in Bezug auf das "Düsseldorfer Verfahren", die von Patentinhabern für sog. "fishing expeditions" ausgenutzt werden könnte.
  
• This position paper of the Max Planck Institute for Innovation and Competition provides comments on the amendments proposed by the German Ministry of Justice and Consumer Protection in its discussion draft of January 2020 on the modernization and simplification of the German Patent Act. While the Institute generally welcomes the initiative, the paper offers some suggestions aimed at increasing precision in the areas of first, the concept and the implementation of the proportionality test for granting injunctive relief, and, second, the need for enhanced protection of trade secrets in patent disputes.
  
  With regard to the proportionality assessment, the Institute suggests that, rather than reducing it to an application of the principle of good faith, the concept of proportionality should be interpreted and applied in light of the ratio legis of patent protection with a view to preventing dysfunctional effects potentially resulting from the exercise of the exclusive right and the associated claim to an injunction. Scenarios involving complex products, non-practicing entities and standard-essential patents are used to illustrate the approach. As regards the weighing and balancing of interests when assessing proportionality, the position paper argues that it is neither desirable nor appropriate to prioritize the interests of the patentee over those of the infringer as a matter of principle. In addition, it is not only the interests of parties to the dispute, but also those of third parties, in particular the public interest, that should be taken into account.
  
  With regard to the protection of trade secrets in patent disputes, the position paper refers to certain procedural insufficiencies of the Trade Secrets Act to adequately protect the defendant’s secrecy interests. It also points out a potential loophole in relation to the "Düsseldorf proceedings" that may facilitate "fishing expeditions".
• Stellungnahme_2020-03-1final.pdf
• Also published at SSRN as Max Planck Institute for Innovation & Competition Discussion Paper No. 16
• English version published under the title: Position Paper on the Envisaged Reform of the German Patent Act as Max Planck Institute for Innovation & Competition Research Paper No. 20-05

Comments of the Max Planck Institute for Innovation and Competition of 11 February 2020 on the Draft Issues Paper of the World Intellectual Property Organization on Intellectual Property Policy and Artificial Intelligence, 2020, 9 S. (gemeinsam mit Josef Drexl et al.).

• WIPO AI Draft Issue Paper_Comments_Max Planck.pdf

Position Statement of the Max Planck Institute for Innovation and Competition of 26 April 2017 on the European Commission's "Public consultation on Building the European Data Economy", 2017, 13 S. (gemeinsam mit Josef Drexl et al.).

• This Position Statement responds to the Communication of 10 January 2017 by which the European Commission launched a public consultation on the future legal framework for data-driven markets that emerge in the course of the current digitization of industrial production and the advent of smart products in which sensors are embedded. In particular, the Position Statement comments the Commission’s ideas on a possible future data producer’s right as a means of promoting access to data. While the Max Plank Institute agrees that there are indeed instances where there is a need to “unlock data”, it rejects a data producer’s right. Rather, the Institute recommends considering more targeted data access rights that would specifically react to situations in which a manufacturer of smart products would otherwise try to reserve related markets for itself. The Max Planck Institute thereby takes inspiration from the data portability right that has already been implemented as part of the Basic Data Protection Regulation. Moreover, general principles on the design of data access regimes are developed. In sum, the Max Planck Institute favours a sector-specific approach to the introduction of a general data access right or a generally applicable data access regime. Sector-specific rules are especially needed for answering more concrete questions such as regarding the person entitled to claim access or the one of whether a data holder should be remunerated for granting access to data.
• MPI_Statement_Public_consultation_on_Building_the_EU_Data_Eco_28042017 Copy.pdf
• Chinese Translation of the Position Statement
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 17-08

Position Statement of the Max Planck Institute for Innovation and Competition of August 16, 2016 - On the current debate on exclusive rights and access rights to data at the European level, 2016, 12 S. (gemeinsam mit Josef Drexl et al.).

• Also published in GRUR Int under the title: Ausschließlichkeits- und Zugangsrechte an Daten - Positionspapier des Max-Planck-Instituts für Innovation und Wettbewerb vom 16.8.2016 zur aktuellen europäischen Debatte, GRUR Int 65,10 (2016), 914 - 918
• This position statement of the Max Planck Institute for Innovation and Competition has been released against the background of the European Free Flow of Data Initiative of the European Commission and the on-going political, economic and academic debate on the related issues. The Institute takes a stance as regards the introduction of exclusive rights in data, special legal protection of algorithms used in data analysis, as well as the questions on the applicability of the current EU legal framework for the sui-generis database rights and trade secrets to individual data and data-sets. The Institute sees no economic justification for the introduction of new exclusive rights in data, which could even hamper the functioning of the data-driven economy. In contrast, the statement emphasizes the importance of access to data in order to ensure the proper functioning of data-driven markets. It identifies the need for further research in this regard and recommends the general approach and principles to be considered if the special regulation of access to data is necessary.
• Positionspaper-Data-Eng-08-31_def-korr Copy.pdf
• Also published as: Max Planck Institute for Innovation & Competition Research Paper No. 16-10 under the title: Data Ownership and Access to Data - Position Statement of the Max Planck Institute for Innovation and Competition of 16 August 2016 on the Current European Debate

Andere Veröffentlichungen, Presseartikel, Interviews

Generative Artificial Intelligence: Addressing Regulatory and Patent Law Challenges, Chinese Social Sciences Today 24.08.2023.

• http://38.83.102.134:81/epaper/zsjxsbd/2023/08/24/A04/4485840.shtml

CRISPR/Cas Technology and Innovation: Mapping Patent Law Issues (Max Planck Institute for Innovation & Competition Research Paper, No. 22-06), 2022, 49 S. (gemeinsam mit Reto M. Hilty et al.).

• The paper provides a systematic overview of issues arising at the interface between CRISPR/Cas technology and patent law. In particular, it examines aspects related to the patentability of CRISPR/Cas-based methods of genome editing, on the one hand, and access to patented technologies, in view of the expanding CRISPR patent landscape, on the other hand. On the whole, our findings show that the case of CRISPR/Cas technology is prototypical of the policy dilemma in patent law as to how to balance economic incentives of multiple innovators in a cumulative innovation setting. The reviewed technical, legal and economic factors suggest the preconditions for technology underutilisation. While this paper presents the results of the exploratory phase of research, it sets a framework for the further, more targeted interdisciplinary examination of the identified issues.
• Available at SSRN

Patent Rights in Pandemic Times, Highlights from the Yearbook of the Max Planck Society 2021 (2022), 26 - 27 (gemeinsam mit Reto M. Hilty, Suelen Carls).

• https://www.mpg.de/18802436/jahrbuch-highlights-2021.pdf

Modernizing German Patent Law: Toward an Explicit Obligation for Proportionality Control of Injunctions?, Oxford Business Law Blog 2020 12.06.2020 (gemeinsam mit Luc Desaunettes-Barbero et al.).